IL305905A - Composite scaffold for the repair, reconstruction, and regeneration of soft tissues - Google Patents

Composite scaffold for the repair, reconstruction, and regeneration of soft tissues

Info

Publication number
IL305905A
IL305905A IL305905A IL30590523A IL305905A IL 305905 A IL305905 A IL 305905A IL 305905 A IL305905 A IL 305905A IL 30590523 A IL30590523 A IL 30590523A IL 305905 A IL305905 A IL 305905A
Authority
IL
Israel
Prior art keywords
composite scaffold
approximately
support structure
scaffold
microporous matrix
Prior art date
Application number
IL305905A
Other languages
Hebrew (he)
Original Assignee
Biorez Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biorez Inc filed Critical Biorez Inc
Publication of IL305905A publication Critical patent/IL305905A/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L71/00—Compositions of polyethers obtained by reactions forming an ether link in the main chain; Compositions of derivatives of such polymers
    • C08L71/02—Polyalkylene oxides
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00—Compositions of proteins; Compositions of derivatives thereof
    • C08L89/04—Products derived from waste materials, e.g. horn, hoof or hair
    • C08L89/06—Products derived from waste materials, e.g. horn, hoof or hair derived from leather or skin, e.g. gelatin
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
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    • D04B21/10—Open-work fabrics
    • D04B21/12—Open-work fabrics characterised by thread material
    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/14—Fabrics characterised by the incorporation by knitting, in one or more thread, fleece, or fabric layers, of reinforcing, binding, or decorative threads; Fabrics incorporating small auxiliary elements, e.g. for decorative purposes
    • D04B21/16—Fabrics characterised by the incorporation by knitting, in one or more thread, fleece, or fabric layers, of reinforcing, binding, or decorative threads; Fabrics incorporating small auxiliary elements, e.g. for decorative purposes incorporating synthetic threads
    • D—TEXTILES; PAPER
    • D06—TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06N—WALL, FLOOR, OR LIKE COVERING MATERIALS, e.g. LINOLEUM, OILCLOTH, ARTIFICIAL LEATHER, ROOFING FELT, CONSISTING OF A FIBROUS WEB COATED WITH A LAYER OF MACROMOLECULAR MATERIAL; FLEXIBLE SHEET MATERIAL NOT OTHERWISE PROVIDED FOR
    • D06N3/00—Artificial leather, oilcloth or other material obtained by covering fibrous webs with macromolecular material, e.g. resins, rubber or derivatives thereof
    • D06N3/0043—Artificial leather, oilcloth or other material obtained by covering fibrous webs with macromolecular material, e.g. resins, rubber or derivatives thereof characterised by their foraminous structure; Characteristics of the foamed layer or of cellular layers
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A61F2002/0081—Special surfaces of prostheses, e.g. for improving ingrowth directly machined on the prosthetic surface, e.g. holes, grooves
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Claims (41)

1.Claims1. A composite scaffold comprising: a three-dimensional support structure defined by first and second outer layers separated by an interior space, a plurality of spacer elements extending through the interior space and connecting the first and second outer layers; and a microporous matrix disposed in the interior space and having a multitude of interconnected pores collectively defining void space between first and second outer layers of the support structure.
2. The composite scaffold of claim 1 wherein at least approximately 60% of the void space comprises pores having a size dimension of at least 10 μm or greater. 3. The composite scaffold of claim 1 wherein a volume of the void space is between approximately
3.0 cm/gram and 9.0 cm/gram.
4. The composite scaffold of claim 1 wherein composite scaffold has a cross sectional area of approximately between 3 mm and 250 mm, and wherein the cross-sectional area changes less than approximately 17% at a strain percentage of 13%.
5. The composite scaffold of claim 1 wherein a surface area of the composite scaffold is between approximately 0.3 m/gram and 1.5 m/gram.
6. The composite scaffold of claim 1 wherein the composite scaffold has an ultimate stress of approximately between 2.5 MPa and 30 MPa.
7. The composite scaffold of claim 1 wherein the composite scaffold has a yield stress of approximately between 2.5 MPa and 30 MPa.
8. The composite scaffold of claim 1 wherein the composite scaffold has a modulus of approximately between 2.5 MPa and 70 MPa, wherein modulus is calculated using a cross-sectional area of material comprising the composite scaffold and the void space.
9. The composite scaffold of claim 1 wherein the composite scaffold has a modulus of approximately between 150 MPa and 600 MPa, wherein modulus is calculated using a cross-sectional area of only material comprising the composite scaffold.
10. The composite scaffold of claim 1 wherein the three-dimensional support structure comprises a three-dimensional textile structure.
11. The composite scaffold of claim 1 wherein the microporous matrix comprises any of a sponge, foam, or textured fibers or yarns, or any combination thereof.
12. The composite scaffold of claim 1 wherein the microporous matrix comprises any of a freeze-dried sponge, open cell extrusion foam, particulate leached sponge, or any combination thereof.
13. The composite scaffold of claim 11 wherein the microporous matrix comprises any of a sponge, foam, or textured fibers or yarns, or any combination thereof disposed within the scaffold by any of knitting, weaving, lyophilization, particulate leaching, open cell extrusion, solvent casting, solid-state foaming, and cross-linking.
14. The composite scaffold of claim 1 wherein the microporous matrix comprises one of collagen and hydrogel.
15. The composite scaffold of claim 1 wherein the three-dimensional support structure comprises monofilament, multifilament, or textured yarns, or any combination thereof, knitted into a three-dimensional structure.
16. The composite scaffold of claim 1 wherein the three-dimensional support structure comprises any combination of synthetic bioresorbable polymers, natural polymers and/or additives.
17. The composite scaffold of claim 1 wherein the three-dimensional support structure comprises any of homopolymers, copolymers, or polymer blends of any of the following: polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxyalkanoates, polyanhydrides, poly(ortho esters), polyphosphazenes, poly (amino acids), polyalkylcyanoacrylates, poly(propylene fumarate, trimethylene carbonate), poly(glycerol sebacate), poly(glyconate), poly(ethylene glycol), poly(vinyl alcohol) and polyurethane, or any combination thereof.
18. The composite scaffold of claim 1 wherein at least approximately 70% of the void space comprises pores having a size dimension of 10 μm or greater.
19. The composite scaffold of claim 1 wherein at least approximately 80% of the void space comprises pores having a size dimension of 10 μm or greater.
20. The composite scaffold of claim 1 wherein the composite scaffold has a stiffness of approximately between 2.5 N/mm and 25 N/mm.
21. The composite scaffold of claim 1 wherein the composite scaffold has an ultimate load of approximately between 20% and 70%.
22. The composite scaffold of claim 1 wherein the composite scaffold has an ultimate load approximately between 100 N and 200 N.
23. The composite scaffold of claim 1 wherein a surface area of the composite scaffold is between approximately 0.3 m2/gram and 15.0 m2/gram.
24. The composite scaffold of claim 1 wherein a surface area of the composite scaffold is between approximately 0.6 m2/gram and 1.2 m2/gram.
25. The composite scaffold of claim 1 wherein a surface area of the composite scaffold is between approximately 0.7 m2/gram and 1.0 m2/gram.
26. The composite scaffold of claim 1 wherein the microporous matrix comprises a multitude of interconnected pores having a median pore size of between approximately 10 μm to 100 μm.
27. The composite scaffold of claim 1 wherein the microporous matrix comprises a multitude of interconnected pores having a median pore size of between approximately 12 μm to 70 μm.
28. The composite scaffold of claim 13 wherein the microporous matrix comprises a multitude of interconnected pores having a median pore size of between approximately 20 μm to μm.
29. A method of making a composite scaffold comprising: A) constructing a three-dimensional support structure by knitting a scaffold comprising first and second layers spaced apart to define an interior space therebetween but attached together by a plurality of spacer elements extending through the interior space, the support structure extending along a length dimension between first and second ends thereof; and B) forming a microporous matrix within the interior space, the microporous matrix having a multitude of interconnected pores in fluid communication with exterior surfaces of the support structure, wherein a plurality of the interconnected pores are oriented relative to a dimensional characteristics of the support structure.
30. The method of claim 29 wherein the plurality of interconnected pores are oriented radially inward into the interior space from exterior surfaces of the support structure.
31. The method of claim 29 wherein the plurality of interconnected pores are oriented towards the length dimension of the support structure.
32. The method of claim 29 wherein the support structure has an exterior profile and B) comprises: B1) disposing the support structure into a solution filled mold having a cross-sectional profile which at least partially mimics the exterior profile of the support structure, and B2) changing the temperature of the mold to cause crystallization of the solution within the interior space of the support structure.
33. The method of claim 29 further comprising: C) at least partially covering the support structure with a hydrophilic substance.
34. The method of claim 33 wherein at least partially covering the three-dimensional support structure with a hydrophilic substance occurs before disposing a microporous matrix within the interior space.
35. The method of claim 33 wherein the hydrophilic substance at least partially comprises polyethylene glycol (PEG).
36. The method of claim 29 wherein the microporous matrix comprises one of collagen and hydrogel.
37. The method of claim 29 wherein the support structure comprises a scaffold comprises any combination of synthetic bioresorbable polymers, natural polymers and/or additives.
38. The method of claim 37 wherein the scaffold comprises monofilament, multifilament, or multifilament and textured yarns, or any combination thereof, knitted into a three-dimensional structure.
39. The method of claim 29 wherein the microporous matrix comprises any of a sponge, foam, or textured fibers or yarns, or any combination thereof.
40. The method of claim 29 wherein the microporous matrix comprises any of a freeze-dried sponge, open cell extrusion foam, particulate leached sponge, or any combination thereof.
41. The method of claim 29 wherein B) comprises forming the microporous matrix by any of lyophilization, particulate leaching, open cell extrusion, solvent casting, solid-state foaming, and cross-linking.
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